SGLT-2 Inhibitors May Be Linked to Ketoacidosis
May 15, 2015 – The U.S. Food and Drug Administration’s (FDA) issued a warning that the newest class of diabetes medications, call sodium-glucose transporter-2 (SGLT2) inhibitors, may been linked to ketoacidosis. Ketoacidosis is a serious condition where the body produces high levels of blood acids, called ketones, and for some patients, hospitalization may be required. SGLT2 inhibitors include Invokana (canagliflozin - Janssen), Farxiga (dapagliflozin - AstraZeneca) and Jardiance (empagliflozin – Boehringer Ingelheim / Lilly), and they are also included in some combination products. The FDA identified 20 cases of ketoacidosis in patients treated with SGLT2 inhibitors from March 2013 to June 2014 during its review of post-marketing safety information. The FDA will continue to investigate this safety issue and make a decision regarding whether changes should be required in the product labeling for SGLT2 inhibitors.
Patients taking SGLT2 inhibitors should not stop or change their diabetes medications without talking to their prescribers first, as noted by the FDA. However, patients should seek medical attention immediately if they have symptoms of ketoacidosis, such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.